Steven Charles. Hodgkinson et al.

Patent Trials and Appeals Board

Jun 2, 2020

12682582 - (D) (P.T.A.B. Jun. 2, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/682,582 09/21/2010 Steven Charles Hodgkinson DAIRY88.052APC 3750
20995 7590 06/02/2020
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
KRISHNAN, GANAPATHY
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
06/02/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
efiling@knobbe.com
jayna.cartee@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte STEVEN CHARLES HODGKINSON,
CHRISTOPHER PAUL MCJARROW,
MURRAY D. MITCHELL, ANGELA MARIE ROWAN,
JOANNE MARGARET TODD, and
MARK HEDLEY VICKERS1
________________

Appeal 2019-004320
Application 12/682,582
Technology Center 1600
________________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN G. NEW, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1We use the word “Appellant” herein to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies Fonterra Co-Operative Group
Limited as the real party-in-interest. App. Br. 3.
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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 32–34, 45, 47–51, 53, 54, and 56–65
as unpatentable under 35 U.S.C. § 103 as being obvious over the
combination of Shulman et al. (WO 2006/114790 A2, November 2, 2006)
(“Shulman ’790”), Shulman et al. (WO 2005/051091 A1, June 9, 2005)
(“Shulman ’091”), Fletcher et al. (WO 2006/041316 A1, April 20, 2006)
(“Fletcher”), and Beermann et al. (WO 2006/019300 A2, February 23, 2006)
(“Beermann”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed one or more complex lipids,
including gangliosides, to achieve particular health benefits including
maintaining or increasing cognitive development or maintaining or
increasing growth in a fetal, infant, or child subject. Abstr.

REPRESENTATIVE CLAIM
Claim 32 is representative of the claims on appeal and recites:
32. A method for maintaining or increasing cognitive
development of a foetal, infant, or child subject by orally
administering a composition formulated to comprise comprising
one or more complex lipids to a mother during gestation or an
infant or child subject in need thereof, wherein the one or more
complex lipids comprises one or more gangliosides, and wherein
the composition comprises up to 19 grams of the one or more
complex lipids per 100g on a dry basis and at least 8 mg
gangliosides per 100g on a dry basis, and wherein the one or
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more gangliosides comprises GM3, GD3, or a mixture of at least
GM3 and GD3.

App. Br. 21.

ISSUES AND ANALYSES
We adopt the Examiner’s findings, reasoning, and conclusion that the
claims on appeal are obvious over the prior art cited by the Examiner. We
address the arguments raised by Appellant below.

Issue 1
Appellant argues that the Examiner erred in finding that the combined
cited prior art teaches or suggests the use of gangliosides as constituents of
the claimed composition or as improving or maintaining cognitive
development. App. Br. 10.

Analysis
The Examiner finds that Shulman ’790 teaches compositions
comprising phospholipids, including sphingomyelin, from milk for infants
and young children and pregnant women. Final Act. 3 (citing Shulman ’790
10). The Examiner finds that the compositions of Shulman ’790 can contain
a wide percentage range of polar lipids, including phosphatidylcholine,
phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, and
sphingomyelins. Id. (citing Shulman ’790 13, 24–27). The Examiner finds
that Shulman ’790 teaches that these constituents are known to play a very
important role in the nutrition of developing infants and are useful for
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enhancement of infants’ and/or childrens’ development, particularly
cognitive development. Id. at 4 (citing Shulman ’790 1, 16, 17, 28, 30, 31).
The Examiner finds that Shulman ’790 does not expressly teach
gangliosides as components as constituents of its compositions. Final Act.
4. However, the Examiner finds that Shulman ’091 teaches that human milk
fat has all of the ingredients claimed in Appellant’s composition and that
phospholipids show a variety of health benefits which include improvement
of cognitive functions, and contribution to general well-being of infants,
young children, and pregnant women, and enhancement of fetal
development. Id. (citing Shulman ’091 1–5, 11, 16, 42).
The Examiner finds that Fletcher teaches compositions comprising
complex lipids including at least 0.1 % w/w ganglioside GD3,
sphingomyelin, and phospholipids. Final Act. 4 (citing Fletcher 24, Table
6). The Examiner finds that Fletcher further teaches that the composition
can also contain sphingolipids. Id. (citing Fletcher 5). The Examiner finds
that the ingredients are obtained from milk fat globules via extraction. Id.
(citing Fletcher 9, 13, 14). The Examiner finds that compositions A–D of
Fletcher, as disclosed in Table 6, consist of about 52% lipids, about 23–31%
phospholipids, about 5–8% phosphatidylcholine, about 6–9%
phosphatidylethanolamine, about 2–3% of phosphatidylserine, about 1–2%
phosphatidylinositol, about 6–7% sphingomyelin and 1% gangliosides. Id.
at 4–5 (see also Fletcher 1). The Examiner finds that the compositions of
Fletcher produces health benefits for infants and children. Id. at 5 (citing
Fletcher 9, 13). The Examiner also finds that Fletcher teaches that
increasing the levels of phospholipids and glycosphingolipid in infant
formulations to the levels found in human milk (particularly gangliosides
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GM3, GD3, ceramides and sphingomyelin) lead to optimal neural
development, and that it is therefore desirable to produce infant formula
containing sufficient amounts of these desirable lipids. Id. (citing Fletcher
1–2). The Examiner therefore reasons that Fletcher suggests to the skilled
artisan the inclusion of gangliosides GM3 and GD3 in the composition of
Shulman ’091, because Shulman ’091 teaches the same constituents as
Fletcher and the same purpose in providing health benefits, and also teaches
adjusting the amounts of the complex lipids, including gangliosides. Id.
The Examiner finds that Beermann is directed to infant formulae, and
teaches that gangliosides are a preferable component in its formulae. Final
Act. 5 (citing Beermann 4). The Examiner finds that Beermann teaches
gangliosides preferably present at between 0.1 and 10 grams per 100g dry
weight in the composition. Id. (citing Beermann 5).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to make the claimed compositions and use them in
the claimed methods, because the ingredients recited in the instant claims are
taught in the prior art to be individually useful for increasing and/or
maintaining the cognitive development and growth of fetal, infants and
children. Final Act. 6. The Examiner reasons that a skilled artisan would
have been motivated to make and use the compositions in the claimed
methods since they are obtained from easily available sources, such as milk
dairy products, and because increasing the level of phospholipid and
ganglioside levels in infant formulations have beneficial effects in addition
to enhancing/improving cognitive effects and growth in fetuses, infants and
young children, as taught by Shulman ’091 and Fletcher, and because
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compositions comprising gangliosides also offer protection against allergies
and infection. Id. (citing Beermann Abstr.).
Finally, the Examiner concludes that it would have been well within
the level of skill of one skilled in the art to adjust the amounts of the
components in the compositions taught by the references, so as to optimize
the beneficial effects based on the teachings of the prior art. Final Act. 7.
Appellant first notes that, on July 13, 2015, the Examiner issued a
Notice of Allowability (the “Notice”) in view of Appellant’s prior
submissions, acknowledging that the method claims were not obvious over
Fletcher, Shulman ’790, and Shulman ’091. App. Br. 9. According to
Appellant, the Examiner acknowledged that Fletcher does not teach or
suggest using its composition in a method for maintaining or increasing
cognitive development. Id. at 9–10 (citing Notice 6–7). Appellant asserts
that the Examiner also acknowledged that neither Shulman ’790 nor
Shulman ’091 teach the use of gangliosides as components in their
compositions, and that these references do not teach that gangliosides
improve or maintain cognitive development. Id. at 10. Specifically,
Appellant notes that the Examiner stated:
There is no teaching, suggestion or motivation in the combined
teachings of the cited prior art to administer orally a composition
comprising at least 8mg gangliosides per 100g on a dry basis in
the claimed methods of improvement or maintenance of
cognitive development in a foetal, infant, or child subject as
instantly claimed.

Id. at 10 (quoting Notice 7). Appellant contends that there is no new
evidence that the references teach or suggest the claimed methods, or that
the cited references discloses a composition comprising at least
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8mg gangliosides per 100 g on a dry basis for use in a method for
improvement or maintenance of cognitive development in a foetal, infant, or
child subject, as recited by independent claims 32 and 34. Id.
Specifically, Appellant argues that Shulman ’790 does not teach the
inclusion of gangliosides in a composition or suggest that gangliosides have
any role in cognitive development of a fetal, infant, or child subject. App.
Br. 10. Rather, argues Appellant, Shulman ’790 teaches “polar lipid
preparations, in particular mixtures comprising glycerophospholipids,
optionally with sphingomyelin.” Id. (citing Shulman ’790 1). Appellant
asserts that gangliosides are neither glycerophospholipids nor
sphingomyelin, and the effect of these components on cognitive
development is irrelevant to Appellant’s independent claims 32 or 34, which
relate to complex lipids comprising one or more gangliosides. Id.
Appellant contends that, similarly, Shulman ’091 does not teach
compositions including gangliosides, or any discussion of the role
gangliosides perform in cognitive development. App. Br. 10. Appellant
points to the Examiner’s finding that Shulman ’091 teaches that
“phospholipids show a variety of health benefits which include improvement
of cognitive functions and contribution to general well-being.” Id. at 10–11
(quoting Final Act. 4). Appellant contends that, whether phospholipids have
any effect on cognitive development of infants or children is irrelevant to the
pending claims, as gangliosides are not phospholipids. Id. at 11.
Appellant argues that, although Fletcher teaches the inclusion of
gangliosides in infant formulas, it fails to link a composition including
gangliosides to a method for improving or maintaining cognitive
development of a fetal, infant, or child subject. App. Br. 11. Appellant
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points to the Examiner’s finding that Fletcher teaches that: “Research over
the last 5–10 years has shown that increasing phospholipid and
(glyco)sphingolipid levels in infant formulations to levels found in human
milk (particularly ganglioside GM3, ganglioside GD3, ceramides and
sphingomyelin) may lead to: … optimal neural development.” Id. at 11
(quoting Fletcher 1–2).
Appellant contends that this teaching of Fletcher is deficient for three
reasons. App. Br. 11. First, Appellant argues, Fletcher fails to link any
specific components of the formulations to any specific benefit. App. Br.
11. Appellant asserts that there is no specific linking of gangliosides to any
benefit but, rather, only a linking of the entire formulation, including
sphingomyelin and ceramides, to neural development. Id. According to
Appellant, any of the various components could be alleged to be responsible
for optimal neural development. Id. As such, argues Appellant, Fletcher
fails to provide a reason to select not only the specific combination but also
the amounts of gangliosides recited in claims 32 and 34. Id.
Second, Appellant argues that, even if gangliosides had been linked
directly to neural development by Fletcher, the specific amount claimed in
the present application is not. Final Act. 11. Third, Appellant contends,
neural development is an extremely vague term that is undefined in Fletcher
and is not synonymous with cognitive development, as recited in the claims
on appeal. Id. Appellant asserts that: “Neural development could refer to a
dissimilar array of aspects of neural structures and functions, including birth
of neurons, migration of neurons, neuron connection, neuron receptors,
synaptic formation and plasticity, birth of glia, myelination, muscle control,
sensation, or autonomic function, or others.” Id. at 12. In contrast,
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Appellant points to the Specification’s disclosure that: “The terms
‘increasing cognitive development’ or ‘to increase cognitive development’
are used interchangeably herein and refer to increasing the rate, ability,
interest, willingness, or openness to learn, remember or apply knowledge. In
some embodiments, ‘cognitive development’ refers to brain weight and
brain ganglioside content.” Id. (quoting Spec. ¶ 59).
Appellant argues further that the Examiner acknowledges that
“Fletcher does not teach … enhancement/maintenance of cognitive
development.” App. Br. 12 (quoting Final Act. 10). Appellant therefore
contends that, because Fletcher fails to explicitly link gangliosides with
cognitive development, as that term is defined in Appellant’s Specification,
the teaching of Fletcher do not cure the alleged deficiencies of Shulman ’790
and Shulman ’091. Id. Rather, Appellant argues, the Examiner is
impermissibly relying on hindsight analysis by using the disclosures of
Appellant’s Specification as a roadmap to arrive at the claimed methods. Id.
With respect to Beermann, Appellant argues that the reference is
merely cumulative to the other art of record, at least with respect to Fletcher,
and fails to cure the alleged deficiencies in the other references. App. Br.
12. According to Appellant, Beermann’s teaching that its composition
preferably comprises between 0.1 and 10 grams acidic oligosaccharides per
100 gram dry weight of the composition is not an indication that
gangliosides may be included in this amount. Id. Appellant contends that
the acidic oligosaccharide comprises at least one acidic group selected from
a specific list, and although N-acetylneuraminic acid (which is a component
of gangliosides) is listed as one of the acidic groups, Appellant asserts that
there is no mention of gangliosides in the discussion of acidic
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oligosaccharides. Id. at 12–13. Appellant also contends that Beermann fails
to teach that the formula therein can be used to improve or maintain
cognitive development, as recited by the claims. Id. at 13.
Finally, Appellant argues, the Examiner did not properly assert that
the amount of gangliosides is a result-effective variable, because the cited art
does not recognize any specific relationship between gangliosides and
cognitive development. App. Br. 13. Appellant contends that a result-
effective variable is not simply a variable that can be optimized, but must
rather be shown to achieve a recognized result. Id. (citing, e.g., MPEP
§ 2144.05(Il)(B); In re Antonie, 559 F.2d 618, 620 (C.C.P.A. 1977).
Appellant argues that, other than asserting that the amount of ganglioside
“can be optimized,” the Examiner did not establish that the amount of
ganglioside is, in fact, a result-effective variable. Id.
We are not persuaded by Appellant’s arguments. As an initial matter,
the fact that the Examiner issued, on July 13, 2015, a Notice of Allowability
for the claims on appeal is of no moment in our analysis. If the Examiner
makes a determination different from a determination previously made
during prosecution, that is permissible so long as it is properly grounded, as
here, in the evidence of record. See In re Ruschig, 379 F.2d 990, 992–993
(C.C.P.A. 1967) (“There is nothing unusual, certainly, about an examiner
changing his viewpoint as to the patentability of claims as the prosecution of
a case progresses, and, so long as the rules of Patent Office practice are duly
complied with, an applicant has no legal ground for complaint because of
such change in view”).
We acknowledge that neither Shulman ’790 nor Shulman ’091
expressly teach gangliosides, including those specifically recited in the
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independent claims. However, Shulman ’091 is directed to: “[A]
substantially homogenous lipid preparation comprising a combination of
glycerophospholipids being phosphatidylcholine (PC),
phosphatidylethanolamine (PE), phosphatidylserine (PS) and
phosphatidylinositol (Pl), wherein the quantitative ratio between said
glycerophospholipids essentially mimics their corresponding ratio in
naturally occurring human milk fat (HMF).” Shulman ’091 p. 11. Shulman
’091 also teaches that: “In a preferred embodiment, the lipid combination of
the invention optionally further comprising sphingomyelin (SM) and/or
cholesterol, wherein the quantitative ratio between the glycerophospholipids
in said combination and the sphingomyelin and/or cholesterol essentially
mimics their corresponding ratio in said naturally occurring HMF.” Id.
Shulman ’091 further teaches that “[t]he amount of phospholipids
(sphingomyelin and glycerophospholipids) in human milk fat is about 15-20
mg/dL” and that “[s]ome phospholipids, and especially those extracted from
soybean, are used as dietary supplements and a variety of health benefits are
associated with their intake. These benefits include the improvement of
cognitive functions, improvement of memory and concentration,
maintenance of cellular membrane composition, and contribution to general
well-being.” Id. at 4.

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Similarly, Shulman ’790 teaches:
In [Shulman ’091], the inventors used pure bovine milk
sphingomyelin, obtainable as an analytical standard or research
chemical, which is not particularly suitable for use in infant
nutrition or dietary supplements due to its high cost and
extremely low availability, as mentioned previously.

Thus, it is a purpose of the current invention to provide polar
lipid preparations mimicking the polar lipids of HMF, optionally
comprising [sphingomyelin], wherein the source of said polar
lipids is a natural non-brain lipid source.

It is another object of the present invention to provide a dietary
supplement which guarantees the sufficient and recommended
intake of phospholipids, especially of PS and sphingomyelin, in
the form of a mimetic substitute of the phospholipids from
human breast milk lipid, aimed especially for infants and young
children consumption, as well as pregnant women.

Shulman ’790 p. 10. Shulman ’790 also teaches that: “Still further, the lipid
mixtures and preparations of the invention and the dietary supplements,
nutrients or food articles comprising them may be used in the enhancement
of infants and/or children development, particularly cognitive development
and/or in the enhancement of vision development.” Id. at 16.
Fletcher teaches that:
[S]tandard infant formulas are typically produced using low-fat
dairy products such as skim milk. Using a reduced-fat dairy
product means undesirable components in milk fat are not
included in the infant formula, but it also means that
phospholipid and (glyco)sphingolipid levels are significantly
lower than those in human milk.

Research over the last 5-10 years has shown that increasing
phospholipid and (glyco)sphingolipid levels in infant
formulations to levels found in human milk (particularly
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ganglioside GM3, ganglioside GD3, ceramides and
sphingomyelin) may lead to:

- enhanced gut maturation, thereby reducing the risk of
infection;

- prevention of infections by modifying gut intestinal
flora and competitively binding antigens;

- prevention of the development of allergies; and

- optimal neural development.

It is therefore desirable to produce an infant formula containing
sufficient levels of desirable lipids while minimising or
eliminating undesirable ingredients.

Fletcher 1–2.2
Table 6 of Fletcher shows the lipid composition of its exemplary
products A-E:

2 It is useful to point out at this juncture that the gangliosides present in
human milk fat recited in Appellant’s claims on appeal are
(glyco)sphingolipids closely related to the sphingomyelin recited in
Shulman ’790 and Shulman ’091, sharing the same N-acetylneuraminic
acid – saturated lipid chain, but with a phosphate group in sphingomyelin
and multiple cyclic carbohydrates in gangliosides. See Sphingolipids -
Chemistry and Biochemistry: An Introduction, available at:
https://www.lipidhome.co.uk/lipids/sphingo/introsph/index.htm (last
visited May 29, 2020).
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Table 6 of Fletcher shows the lipid compositions of its
exemplary products A-E

We note here that Table 6 of Fletcher lists, as constituents of its “Total
Lipids” those phospholipids taught by Shulman ’790 and ’091, viz.,
phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, and
phosphatidylinositol (see, e.g., Shulman ’091 4), and sphingomyelin, as well
as gangliosides GD3 and GM3.
We agree with the Examiner that a person of ordinary skill in the art
would have recognized, from the combined teachings of Shulman ’790,
Shulman ’091, and Fletcher that gangliosides, together with phospholipids
and sphingomyelin, are constituents of human milk fat. A skilled artisan
would also understand that whereas Shulman ’790 and Shulman ’091 teach
that its compositions, which approximate the lipid content of human milk fat
maintain and increase cognitive development in fetuses, infants, and
children, Fletcher teaches that its compositions promote at least “optimal
neural development” which would include within its scope “maintain[ing]
and increase[ing] cognitive development” that is also promoted by the
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phospholipids and sphingomyelin that are taught by both Fletcher and the
Shulman references.
Beermann is also directed to “a nutritional composition … particularly
suited for feeding infants as it mimics the protective effects of human milk.”
Beermann, Abstr. In relevant part, Beermann teaches:
Preferably the NCC [negatively charged non-proteineous glycan
and glycoconjugate component] is selected from the group
consisting of glycosphingolipids, acid oligosaccharides, and
sialysated oligosaccharides. Preferably the sialysated
oligosaccharides is sialyllactose and/or disialo-lactoneotertaose
(DS-LNT). Glycosphingolipids are typically compounds with a
monosaccharide attached directly to a ceramide.

Preferably the NCC contains a ganglioside (a
glycosphingolipid). Gangliosides are typically highly complex
oligoglycosylceramides, which contain one or more sialic acid
groups (N-acyl, especially acetyl, derivatives of neuraminic acid,
abbreviated to “NANA”) in addition to glucose, galactose and
galactosamine. For this application, especially buttermilk, egg
yolk lecithin are suitable raw material sources of gangliosides.
Hence the present composition preferably contains egg yolk
lecithin and/or buttermilk.

In a particularly preferred embodiment the present composition
contains a ganglioside selected from the group consisting GM3,
GM1 and GD1.

Beermann 4 (emphasis added, external reference omitted). Beermann
further teaches that, with respect to the acid oligosaccharides mentioned in
the passage quoted supra: “The present composition preferably contains
between 0.1 and 10 grams acid oligosaccharides per 100 gram dry weight of
the present composition, more preferably between 1 and 6 grams per 100
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gram dry weight.” Id. at 5.3 As disclosed by the Specification, therefore,
the acid oligosaccharides of the gangliosides (i.e., sialic acid groups (N-acyl,
especially acetyl, derivatives of neuraminic acid, abbreviated to “NANA” in
addition to glucose, galactose and galactosamine) constitutes between 0.1
and 10 grams per 100 grams dry weight of the composition.
Because the oligosaccharides constitute a substantial portion of the
mass of the ganglioside, we agree with the Examiner that the range taught by
Beermann encompasses Appellant’s claimed range of gangliosides. See In
re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (holding that “[i]n cases
involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness”). We consequently agree with the Examiner that the

3 For the sake of clarity, gangliosides are defined thus:
Glycolipids are biomolecules containing one or more
carbohydrate residues linked to a hydrophobic lipid moiety
through a glycosidic linkage. Glycolipids containing either a
sphingoid or a ceramide as the hydrophobic lipid moiety are
referred to as glycosphingolipids.… Acidic glycosphingolipids
containing one or more sialic acid (N-acetylneuraminic acid or
N-glycolylneuraminic acid) residue(s) in their carbohydrate
moiety are especially referred to as gangliosides. Figure 1 depicts
a common brain ganglioside, GM1.

Figure 1 of Yu depicts the structure of ganglioside GM1
R.K. Yu et al., Structures, biosynthesis, and functions of gangliosides—An
overview, 60(10) J. OLEO. SCI. 537–44 (2011).
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combined cited prior art references teach or suggest the limitations of the
claims on appeal.
Finally, with respect to Appellant’s argument that the Examiner did
not properly assert that the amount of gangliosides is a result-effective
variable, because the cited art does not recognize any specific relationship
between gangliosides and cognitive development (see App. Br. 13), Fletcher
teaches that “Research over the last 5–10 years has shown that increasing
phospholipid and (glyco)sphingolipid levels in infant formulations to levels
found in human milk (particularly ganglioside GM3, ganglioside GD3,
ceramides and sphingomyelin) may lead to: … optimal neural
development.” Fletcher 1–2. We agree with the Examiner that a person of
ordinary skill in the art could reasonably infer from this teaching that the
levels of gangliosides, including gangliosides GM3 and GD3 are related to
the level of cognitive development in infants and is consequently a result-
effective variable, and that increasing the levels of ganglioside present in
formulae to levels approaching that found in normal human breast milk
would yield improved cognitive function compared to formulae that were
comparable deficient in these ganglosides.

Issue 2
Appellant argues the Examiner erred because there would have been
no reason to combine the references to arrive at Appellant’s claimed
invention. App. Br. 14.

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Analysis
Appellant argues that, not only is there no specific reason to modify
the references cited by the Examiner to arrive at Appellant’s claimed
invention, the references explicitly teach away from modification in the
manner asserted by the Examiner. App. Br. 14.
In support of these contentions, Appellant points to the Declarations
of Alastair MacGibbon, filed September 12, 2014 (the “MacGibbon
Declaration”) and of Ronald Schnaar, filed September
12th, 2014 (the “Schnaar Declaration”). App. Br. 14. According to
Appellant, the MacGibbon and Schnaar Declarations set out reasons why a
person of skill in the art would not have combined Shulman ’790, Shulman
’091 and Fletcher, identifying teachings away from the asserted
combination. Id. According to Appellant, the MacGibbon and Schnaar
Declarations establish that the various lipid concentrations and processes by
which lipids are obtained is relevant to whether a person of skill in the art
would have read Shulman ’790, Shulman ’091 and Fletcher together. Id.

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Appellant points to the Schaar Declaration as opining that:
The procedures used by Fletcher to generate their products
involved treating beta-serum with near critical CO2. These
conditions are clearly not the same as those used to obtain the
lipid extracts of [Shulman] ’790 or ’091. So it is not evident that
products obtained by these different processes would have the
same specific components or provide the same benefits. For at
least this reason, I would not have combined Fletcher with ’790
or ‘091.

App. Br. 14 (quoting Schaar Decl. ¶ 57).
Appellant similarly cites the MacGibbon Declaration as explaining the
various reasons why a person skilled in the art would not have combined
either Shulman ’790 or Shulman ’091 with Fletcher. App.Br. 14. Appellant
notes that MacGibbon opines that: “At page 8, second paragraph, [Shulman]
’790 criticizes certain preparations such as those of Fletcher, as containing
phospholipid concentrations that are too low and containing undesirable
proteins and carbohydrates.” App. Br. 14 (quoting MacGibbon Decl. ¶ 10).
Similarly, argues Appellant, the MacGibbon Declaration opines that: At
page 8, third paragraph, [Shulman] ’790 states that the ratio of phospholipids
in certain products such as those of Fletcher is undesirable, being too low in
sphingomyelin relative to other phospholipids, and containing too much
non-phospholipid material.” Id.
Appellant contends that the Schnaar and MacGibbon Declarations
provide evidence that the formulations of Shulman ’790 and Fletcher are
incompatible and that Shulman ’790 teaches away from utilizing
phospholipid concentrations at the levels found in Fletcher. App. Br. 14–15.
Furthermore, Appellant argues, the ratio of the various phospholipids in
Fletcher are irreconcilable with the teachings of Shulman ’790. Id. (citing
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MacGibbon ¶ 11). Appellant asserts that the MacGibbon Declaration attests
that preparations, such as those in Fletcher, would be incompatible with
Shulman ’790 because they contain phospholipid concentrations that are too
low, contain undesirable proteins and carbohydrates, contain an undesirable
ratio of phospholipids, particularly sphingomyelin relative to other
phospholipids, and contain too much nonphospholipid material. Id. (citing
MacGibbon Decl. ¶¶ 10–17).
Turning to Beermann, Appellant argues that Beermann teaches that its
compositions provide protective effects against allergies and infection and
stimulates the development of the nervous system of neonates, but Appellant
contends that there is no indication that it increases cognitive development.
App. Br. 15 (citing Beermann Abstr.). Furthermore, contends Appellant,
Beermann provides no evidence to substantiate any utility of its described
compositions. Id. As a result, Appellant asserts, there would have been no
reason to combine Beermann with the other references and to modify its
teachings as asserted by the Examiner. Id.
We are not persuaded by Appellant’s arguments. The Schnaar
Declaration opines that:
The procedures used by Fletcher to generate their products
involved treating beta-serum with near critical CO2. These
conditions are clearly not the same as those used to obtain the
lipid extracts of [Shulman] ’790 or ’091. So it is not evident that
products obtained by these different processes would have the
same specific components or provide the same benefits. For at
least this reason, I would not have combined Fletcher with
[Shulman] ’790 or ’091.

Schnaar Decl. ¶ 57. We do not find this persuasive. Shulman ’091 teaches
compositions comprising a combination of phospholipids (viz.,
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phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, and
phosphatidylinositol) and sphingomyelin. See Shulman ’091 13. Fletcher
teaches compositions comprising the elements listed in Shulman ’091
together with gangliosides GD3 and GM3. See Fletcher Table 6. Even
acknowledging Dr. Schnaar point that the compositions of Shulman ’091
and ’790 were synthesized by a different method from that of Fletcher, the
Schnaar Declaration provides no evidence of record to show that identical
constituents of a nutritional composition (the phospholipids and
sphingomyelin), although synthesized by different means, would not have
the same beneficial nutritional effects.
The MacGibbon Declaration states that:
[Shulman] ’790 clearly indicates that certain known
compositions comprising polar lipids are undesirable to use. At
page 8, second paragraph, [Shulman] ’790 criticises certain
preparations such as those of Fletcher, as containing
phospholipid concentrations that are too low and containing
undesirable proteins and carbohydrates. At page 8, third
paragraph, [Shulman] ’790 states that the ratio of phospholipids
in certain products such as those of Fletcher is undesirable, being
too low in sphingomyelin relative to the other phospholipids, and
containing too much non-phospholipid material.

MacGibbon Decl. ¶ 10. Shulman ’790 teaches that:
[T]he dairy industry has started to utilize dairy waste to produce
nutritional preparations which contain milk proteins,
carbohydrates and small amounts of lipids. The latter include
neutral lipids as well as polar lipids, including
glycerophospholipids as well as sphingolipids, among them
sphingomyelin. These preparations contain extremely low levels
of sphingomyelin and phosphatidylserine, making them
incompatible as an industrial source for these nutrients.

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Shulman ’790 8. It is by no means evident that the nutritional preparations
produced by “the dairy industry” includes the preparations of Fletcher, but it
is immaterial of they do. In an obviousness analysis:
The test … is not whether the features of a secondary reference
may be bodily incorporated into the structure of the primary
reference; nor is it that the claimed invention must be expressly
suggested in any one or all of the references. Rather, the test is
what the combined teachings of the references would have
suggested to those of ordinary skill in the art.

In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). The issue, then is not
whether the compositions of Fletcher could be physically combined with
those of Shulman ’790 and/or ’091, but is rather what the combined
teachings of the references would have suggested to a person of ordinary
skill. We conclude that a person of ordinary skill in the art, upon
comprehending the teachings of Shulman ’790 that extremely low levels of
sphingomyelin and phospholipids are “incompatible as an industrial source
for these nutrients” would have been motivated to combine the teachings of
Shulman ’790 and ’091 with Fletcher to achieve higher concentrations of
phospholipids and sphingomyelin, along with the ganglioside concentrations
taught by Fletcher.
The MacGibbon Declaration further states that “[i]n view of these
passages, I would not have considered the extracts of Fletcher to be polar
lipid preparations within the scope of ’790.” MacGibbon Decl. ¶ 13. But
whether the teachings of Fletcher are “within the scope of” the teachings of
Shulman ’790 (or ’091) is irrelevant to our obviousness analysis. What is
relevant, again, is what the combined teachings of the references would
suggest to a person of ordinary skill in the art. Keller, 642 F.2d at 425. One
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cannot show non-obviousness by attacking references individually where …
the rejections are based on combinations of references.” Id. at 426.
We are therefore not persuaded that a person of ordinary skill in the
art would have had no reason to combine the teachings of Shulman ’790 and
’091 and Fletcher. Nor are we persuade that there is a teaching away from
Appellant’s claimed invention in the cited prior art. A reference teaches
away when “a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Appellant points to no evidence
of record teaching or suggesting that the compositions taught by Shulman
’790, Shulman ’091, Fletcher, and Beermann could not be combined,
specifically, that the high concentrations of phospholipids and
sphingomyelin taught by Shulman ’790 could not be combined with the
gangliosides taught by Fletcher. Appellant points to, with no evidence of
record that would discourage or divert a skilled artisan from combining the
references.
Finally with respect to Fletcher and Beermann, Fletcher teaches that:
“Research over the last 5-10 years has shown that increasing phospholipid
and (glyco)sphingolipid levels in infant formulations to levels found in
human milk (particularly ganglioside GM3, ganglioside GD3, ceramides and
sphingomyelin) may lead to…optimal neural development.” Fletcher 1–2.
Beermann teaches “The present nutritional composition is particularly
effective in … [s]timulating the development of the nerve system of
neonates. Beermann 1–2. Even acknowledging that these references do not
necessarily teach “maintaining or increasing cognitive development of a
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foetal, infant, or child subject” as recited in the claims, we nevertheless
agree with the Examiner that a person of ordinary skill in the art would
understand that without “optimal neural development” and “[s]timulating the
development of the nerve system” there can be no maintenance or increase
in cognitive function, as the relationship between neural development and
cognitive function is well known in the art. We are consequently not
persuaded by Appellant’s arguments.

Issue 3
Appellant argues that their evidence of surprising or unexpected
results is sufficient to overcome the Examiner’s prima facie conclusion of
obviousness. App. Br. 16–17.

Analysis
Appellant points to the Schnaar Declaration, and to the Declaration of
Angela Rowan, Angela Rowan (filed September 24, 2013) (the “Rowan
Declaration”) as supporting their contention that the presence of an
unexpected property of gangliosides in the claimed compositions was
unexpected. App. Br. 17.
Appellant points to the Rowan Declaration as opining that:
As reported in the Application, an animal study using a complex
milk lipid source of gangliosides demonstrated a significant
improvement in rate of learning and exploring activity, and in
bone density and body length in supplemented
animals compared to controls when supplementation was
extended beyond weaning. These results have been reported as
Vickers M, Guan 3, Gustavsson M, et al[.,] Supplementation
with a mixture of complex lipids derived from milk to
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growing rats results in improvements in parameters related to
growth and cognition. Nutr. Res. 2009 29: 426-35.4

These results were surprising because although gangliosides are
recognized components of cell membranes in the brain, there
have been no previous reports of gangliosides being orally active
in cognitive development or in aspects of healthy growth, and
there was no reason to expect that they would be orally active.

App. Br. 17 (quoting Rowan ¶¶ 72–73). Appellant therefore contends that
both the identification of gangliosides as orally active in cognitive
development and the discovery of the specific claimed amount of
gangliosides that can activate this property are unexpected results. Id.
Appellant’s Specification describes the performance of neonate rats
(>22 days post weaning) fed on a diet of low 0.02% (low) to 1% (high)
weight/bodyweight (w/w) gangliosides relative to measured food intake.
Spec. ¶¶ 101–104, 107. Performance of the subjects in a Water Morris Maze
test was then analyzed, and the results are presented in the Specification’s
Figure 1, reproduced below:

4 We note here that Appellant’s application on appeal, filed September 21,
2010, is a continuation of PCT/NZ08/00274, filed October 20, 2008. The
Vickers reference is therefore not prior art with respect to the claims on
appeal.
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Figure 1 of Appellant’s Specification demonstrates the
performance of neonate rats fed high--ganglioside supplement
low-ganglioside supplement, and control diets in the Morris
Water Test

According to the Specification:
There was an improved rate of learning and swim parameters of
distance and speed on day 2 of the acquisition phase in High dose
gel treated animals. But by day four there where [sic] no
significant differences between the groups. The results indicated
the High dose animals learnt the task faster than the control
animals. The analysis indicates the animals did this by shorter
swim distance and without swimming faster.

Spec. ¶ 110.
We are not persuaded. As an initial matter, Appellant relies upon the
Schnaar and MacGibbon Declarations’ opining that: “[N]one of the prior art
suggests that orally administering gangliosides in any amount, let alone in an
amount of at least 8 mg gangliosides per 100 g dry powder as claimed,
would have any effect on cognitive development.” Schnaar Decl. ¶ 67. We
disagree. Fletcher and Beermann expressly teach that gangliosides are an
important component of human breast milk, and Fletcher teaches that
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gangliosides are important for optimal neural development, reasonably
suggesting its use for cognitive development, as well.. See Fletcher 1–2;
Beermann 2. Because human breast milk is perforce administered orally, we
do not share the Declarant’s surprise that increasing the level of ganglioside
in a nutritional formula composition to a level approximating that of human
breast milk would result in increased cognitive performance levels
equivalent to that of children who were fed human breast milk. See Gurnida,
infra.
Nor do we find the data from the studies adduced by Appellant to be
probative of unexpected results. “To be particularly probative, evidence of
unexpected results must establish that there is a difference between the
results obtained and those of the closest prior art, and that the difference
would not have been expected by one of ordinary skill in the art at the time
of the invention.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752
F.3d 967, 977 (Fed. Cir. 2014). Appellant’s Specification does not
demonstrate that the control animals were fed a diet that was as high in
phospholipids as those taught by either Shulman ’790 or Shulman ’091. Nor
is it in evidence that the rats were fed compositions containing equivalent
amount of gangliosides as those described in Fletcher.5 Lacking such

5 We here also note the rather obvious legal conclusion that Appellant’s
proposed unexpected results are not commensurate with the scope of the
claims. Claim 32, for example, recites: “A method for maintaining or
increasing cognitive development of a foetal, infant, or child subject…”
with the clear implication that the subject is human. The Specification’s
subject test animals are weanling/pup Wistar rats, which cannot be
reasonably construed as being infants or children. See Spec. ¶¶ 100, 104–
105.
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comparisons between the Example of the Specification and the teachings of
the prior art, we are not persuaded that the results are unexpected. Thus, the
results described in the Specification were not compared to the closest prior
art.
Moreover, even were we, arguendo, to overlook the differences
between the exemplary disclosure of the Specification and the teachings of
the prior art, we are not persuaded that a small, but significant difference in
the rate of learning at day 2 of the behavioral trials amounts to the requisite
difference in kind, rather than degree, of difference sufficient to be
persuasive of unexpected results. See Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (holding that unexpected results
that are probative of nonobviousness are those that are “different in kind and
not merely in degree from the results of the prior art”) (citation omitted).
We consequently are not persuaded by Appellant that the disclosures of the
Specification are probative of unexpected results.
Appellant also points ou that the Schnaar Declaration points to a prior
art study published by D.A. Gurnida et al, Association of Complex Lipids
Containing Gangliosides with Cognitive Development of 6-month-old
Infants, 88(8) EARLY HUMAN DEV. 595-601 (2012) (“Gurnida”). App. Br.
17 (citing Schnaar Decl. ¶¶ 67–68; also citing Rowan Decl. ¶ 22). The
Schnaar Declaration, in reference to Gurnida, states that, “none of the prior
art suggests that orally administering gangliosides in any amount, let alone
in an amount of at least 8 mg gangliosides per 100 g dry powder as claimed,
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would have any effect on cognitive development.” Schnaar Decl. ¶ 67
(quoting). The Schnaar Declaration opines that:
The results are particularly surprising given that the control
formulation contained gangliosides as well, just at a lower level.
I would not have expected there to be such a significant effect on
cognitive development associated with orally administering at
least 8 mg gangliosides per 100 g dry powder, compared to
administering 6 mg gangliosides.

Schnaar Decl. ¶ 68). Appellant therefore argues that both the identification
of gangliosides as orally active in cognitive development and the discovery
of the specific claimed amount of gangliosides that can activate this property
are unexpected results. Id.
We do not find Appellant’s arguments persuasive. Gurnida teaches a
study comparing cognitive function in infants6 fed on either: (1) standard
infant formula (control); (2) standard infant formula “with added complex
milk lipid to increase the ganglioside GD3 content by approximately 2–3
mg/100 g” (test group); or (3) infants who were breastfed (reference group).
Gurnida 596. Of the compositions fed to the test and control groups,
Gurnida teaches that: “Both study products were similar in composition
(Table 1) except for increased arachidonic acid, phospholipid and
ganglioside contents in the Complex Milk Lipid-supplemented [i.e., test
group] formula.” Id. With respect to the latter, Gurnida teaches that:
“The complex milk lipid ingredient is a natural milk derived component that
is acceptable for use in infant formula, and can be added at a level to give

6 The test subjects were infants fed on the respective diets from 2–8 weeks
of age until 24 weeks of age. Gurnida 596.
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total ganglioside content within the range of ganglioside content in human
breastmilk.” Id. (emphasis added).
Gurnida teaches that:
No significant difference was found between the control and
treatment groups for the Griffith Locomotor, Personal–Social,
and Hearing and Speech scores. However, there was a significant
increase in scores for Hand and Eye Coordination and
Performance and also for Total Score (General IQ) in the
treatment group. Notably, all scores in this group were similar to
those of the reference group (P>0.05; 2 sample t-test using both
adjusted and unadjusted scores for the treatment group).

Gurnida 598. More specifically, with respect to the latter point, Gurnida
teaches that: “Cognitive development scores and serum ganglioside levels
for the treatment group did not differ from the reference group.” Id. at
Abstr.
To summarize, Gurnida teaches that infants fed with the phospholipid
and ganglioside supplement performed significantly better on certain
measures of cognitive development than did those fed on standard infant
formula without supplement. Notably, there was no difference between the
infants fed the supplemented composition and those fed on natural breast
milk, which the supplement was expressly designed to mimic.
We do not find these results to be unexpected or surprising in view of
the teachings of the prior art. Shulman ’091 teaches that “it is an object of
the present invention to provide a dietary supplement which guarantees the
sufficient and recommended intake of phospholipids, in the form of a
mimetic substitute of the phospholipids from human breast milk lipid, aimed
especially for infants and young children consumption, as well as pregnant
women.” Shulman ’091 5. Shulman ’091 further teaches that:
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Some phospholipids, … are used as dietary supplements and a
variety of health benefits are associated with their intake. These
benefits include the improvement of cognitive functions,
improvement of memory and concentration, maintenance of
cellular membrane composition, and contribution to general
well-being.
…
The dietary supplement of the invention are particularly intended
for use in the enhancement of infants and/or children
development, in the enhancement of infants and/or children
cognitive development, in the enhancement of fetal development
and in the enhancement of infants and/or children vision
development.

Id. at 4, 16. Shulman ’091 thus teaches that supplementing infant formula
compositions with phospholipid concentrations approaching that of human
breast milk could be expected to improve cognitive function.
Fletcher teaches that:
[S]tandard infant formulas are typically produced using low-fat
dairy products such as skim milk. Using a reduced-fat dairy
product means undesirable components in milk fat are not
included in the infant formula, but it also means that
phospholipid and (glyco)sphingolipid levels are significantly
lower than those in human milk.

Research over the last 5–10 years has shown that increasing
phospholipid and (glyco)sphingolipid levels in infant
formulations to levels found in human milk (particularly
ganglioside GM3, ganglioside GD3, ceramides and
sphingomyelin) may lead to:… optimal neural development.

Fletcher 1–2. The combined cited prior art thus teaches that increasing the
concentrations of phospholipids and gangliosides to approximate that found
in human breast milk would provide increased neural and cognitive
development compared to standard formula with lower concentrations of
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those constituents. Gurnida validates these teachings of the prior art,
demonstrating that supplementing formula with phospholipids and
gangliosides to approximate the concentrations of those constituents found
in human breast milk provides cognitive benefits that are equivalent to those
derived from a diet of human breast milk. We conclude that a person of
ordinary skill in the art, having comprehended the teachings of Shulman
’091, Shulman ’790, and Fletcher would have predicted the teachings of
Gurnida. We further conclude that the teachings of Gurnida, and
Appellant’s Specification, are therefore not surprising or unexpected. We
consequently affirm the Examiner’s rejection of the claims.

CONCLUSION
The Examiner’s rejection of claims 32–34, 45, 47–51, 53, 54, and 56–
65 under 35 U.S.C. § 103 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
32–34, 45,
47–51, 53,
54, 56–65
103 Shulman ’790,
Shulman ’091,
Fletcher,
Beermann
32–34, 45,
47–51, 53,
54, 56–65